Drug Interaction Study of Colchicine and Theophylline

Completed · Phase 4

Conditions studied: Healthy

In brief

Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe substrate. When the two are co-administered the potential exists for a clinically significant drug interaction. This study aims to determine the effect of steady-state colchicine on the pharmacokinetics of theophylline administered as a single dose. A secondary goal is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the entire study period.

Key facts

Study ID

NCT01601132

Run by

Takeda

People needed

30

Starts

2012-05-01

Expected to finish

2012-07-01

Last updated by the study team

2013-06-17

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults 18-45 years of age, non smoking and non-pregnant (postmenopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive; hemoglobin greater than or equal to 11.5g/dL

You may not qualify if…

• Recent participation (within 28 days) in other research studies
• Recent significant blood donation or donation of plasma
• Pregnant or lactating
• Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
• Recent (2-year) history or evidence of alcoholism or drug abuse
• Subjects who test positive for drugs of abuse or alcohol at screening or check-in
• History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease or active sexually transmitted disease
• History of neuropathy or muscle disorders, peptic ulcer disease, clinically significant cardiac arrhythmias, seizure disorder, and low white blood cell count or other bone marrow disorders
• Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
• History of allergy or sensitivity to colchicine or theophylline or aminophylline
• Subjects who have had a tattoo or body piercing within 30 days prior to administration of study drug
• Subjects with irritable bowel syndrome, chronic diarrhea or other chronic gastro-intestinal problems
• Subjects who are lactose intolerant

Where it is running

• Worlwide Clinical Trials Drug Development Solutions, Clinical Research Services — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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